description

INFORMATION WAS RECEIVED FROM A PROSPECTIVE PATIENT REGARDING A PATIENT WITH AN IMPLANTABLE NEURO STIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAS THE INS AND THE IMPLANT DID NOT WORK FOR HER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THIS EVENT.

other elements

mdr-report-key: 7206038

report-number: 3007566237-2018-00206

manufacturer-link-flag-: Y

adverse-event-flag: N

product-problem-flag: Y

date-report:2018-01-19

reprocessed-and-reused-flag: N

health-professional: I

date-manufacturer-received: 2018-01-17

single-use-flag: Y

previous-use-code: I

date-added: 2018-01-19

date-changed: 2018-01-19

event-type: M

event-type-description: Malfunction

report-source-code: M

report-source-description: Manufacturer report

reporter-occupation-code: 000

reporter-occupation-description: OTHER

initial-report-to-fda: U

initial-report-to-fda-description: Unknown

report-to-fda: *

report-to-fda-description: No answer provided

type-of-report: I

type-of-report-description: Initial submission

source-type: CONSUMER

source-type-description: CONSUMER

event-location: I

name: Medtronic

original-name: MEDTRONIC NEUROMODULATION

street-1: 800 53RD AVE NE

city: MINNEAPOLIS

state-code: MN

zip-code: 55421

zip-code-ext: 1200

country-code: US

postal-code: 554211200

text: IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

text: INFORMATION WAS RECEIVED FROM A PROSPECTIVE PATIENT REGARDING A PATIENT WITH AN IMPLANTABLE NEURO STIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAS THE INS AND THE IMPLANT DID NOT WORK FOR HER. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THIS EVENT.